Contact Information
Address:
2160 W State Road 434, Longwood, FL 32779
Phone:
Website
https://503bcompoundingpharmacy.com/
503B Compounding Pharmacy is an FDA-registered outsourcing facility operating under Section 503B of the Federal Food, Drug, and Cosmetic Act, providing large-scale, sterile compounded medications to healthcare systems across the United States. The pharmacy is built to serve hospitals, surgery centers, clinics, and licensed healthcare providers that require consistent, compliant, and scalable access to compounded pharmaceuticals without patient-specific prescriptions. Operating from its facility at 2160 W State Road 434, Longwood, FL 32779, 503B Compounding Pharmacy follows current Good Manufacturing Practice (cGMP) standards and is subject to routine FDA inspection. This places it in a fundamentally different category than traditional 503A pharmacies. The focus is not retail compounding or one-off prescriptions. The focus is controlled production, batch consistency, sterility assurance, and regulatory discipline. The facility specializes in sterile injectable and non-sterile compounded medications designed to address drug shortages, support procedural efficiency, and improve supply chain reliability for healthcare providers. All production is performed in ISO-classified cleanroom environments using validated processes, documented quality systems, and lot-level traceability. Each batch undergoes appropriate sterility, endotoxin, and potency testing based on risk level and formulation requirements. 503B Compounding Pharmacy prioritizes transparency and compliance over speed or marketing claims. Products are compounded using USP-grade ingredients sourced from vetted suppliers, with full documentation available for healthcare partners. Beyond production, the pharmacy supports client institutions with regulatory documentation, recall readiness, adverse event reporting protocols, and consistent supply planning. The company exists to solve real operational problems for healthcare organizations. Drug shortages, inconsistent manufacturers, and unreliable distributors create risk for patient care. A properly run 503B facility reduces that risk by acting as a compliant, predictable manufacturing partner rather than a reactive supplier.
2160 W State Road 434, Longwood, FL 32779
https://503bcompoundingpharmacy.com/
503B Compounding Pharmacy operates as an FDA-registered outsourcing facility from its location at 2160 W State Road 434, Longwood, FL 32779. This designation under Section 503B of the Federal Food, Drug, and Cosmetic Act establishes a critical standard for quality and safety, distinguishing this facility from traditional compounding pharmacies. The 503B Compounding Pharmacy is dedicated to the large-scale compounding of sterile and non-sterile medications, which are then distributed to healthcare providers for office use and administration to their patients. The core mission is to provide practitioners serving the local community with access to high-quality, compounded medications that are essential for patient care but may be commercially unavailable or in short supply.
The operations at 2160 W State Road 434 are built upon a foundation of rigorous quality control. As an FDA-registered 503B outsourcing facility, the pharmacy adheres to Current Good Manufacturing Practices (cGMP), which are the strict manufacturing standards enforced by the FDA for drug manufacturers. This commitment ensures that every batch of medication produced is consistently pure, potent, and safe. The environment at the Longwood facility is meticulously controlled, with sterile compounds being prepared in ISO-classified cleanrooms by highly trained personnel. This level of quality assurance provides healthcare professionals at 2160 W State Road 434 with the confidence that the medications they use meet the highest possible standards.
503B Compounding Pharmacy provides a vital service to the healthcare ecosystem at 2160 W State Road 434 by compounding medications that are not readily available from standard commercial manufacturers. This includes creating specific strengths or dosages that are not commercially marketed, reformulating medications to exclude non-essential allergens like dyes or preservatives, or producing drugs that are currently on the FDA’s drug shortage list. By addressing these specific needs, the 503B Compounding Pharmacy supports local clinicians in delivering personalized and uninterrupted care to their patients, ensuring that necessary treatments are accessible directly from 2160 W State Road 434.
Engagement with the local medical community is a primary function of the 503B Compounding Pharmacy. The facility serves as a reliable partner for physicians, surgeons, veterinarians, and other healthcare providers who require bulk compounded pharmaceuticals for their practice at 2160 W State Road 434. The team works directly with these professionals, offering a channel for obtaining essential medications that are critical for procedures, treatments, and overall patient therapy. For more detailed information about services or to initiate an order, healthcare providers are encouraged to contact the facility directly. The website, https://503bcompoundingpharmacy.com/, offers comprehensive resources, and the dedicated team can be reached by phone at (407)993-1381 to discuss specific compounding needs.
Frequently Asked Questions for 503B Compounding Pharmacy at 2160 W State Road 434
What does it mean that this is a 503B Compounding Pharmacy?
It means our facility at 2160 W State Road 434 is registered with the FDA as an outsourcing facility under Section 503B of the Federal Food, Drug, and Cosmetic Act. This requires us to comply with more rigorous manufacturing standards, known as Current Good Manufacturing Practices (cGMP), compared to a traditional pharmacy, ensuring a higher level of quality, sterility, and safety for the medications we compound.
Who can order medications from the 503B Compounding Pharmacy?
Our services at 2160 W State Road 434 are designed for healthcare professionals. We provide compounded medications for office use to licensed practitioners, including physicians, surgeons, dentists, and veterinarians, who then administer these medications to their patients within their practice.
Can I as a patient pick up a prescription directly from your location?
No. 503B Compounding Pharmacy operates as a bulk manufacturer for healthcare providers, not as a retail pharmacy. Patients receive their medications directly from their doctor or clinician, who orders and administers the compounded drugs from our facility at 2160 W State Road 434 as part of a treatment protocol.
What kinds of medications do you compound at your Longwood facility?
At our location on W State Road 434, we compound a wide range of sterile and non-sterile medications in larger batches. This includes preparations often used in offices and clinics, such as hormone injections, ophthalmologic solutions, pain management formulations, and other medications that are on shortage or are not available from commercial manufacturers.
How do I, as a healthcare provider, place an order with your facility?
Healthcare providers can place orders by contacting 503B Compounding Pharmacy directly. You can reach our team at (407)993-1381 to discuss your specific needs and requirements. You can also find more information and resources on our website at https://503bcompoundingpharmacy.com/.